Cysto-aurin®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CYSTO-AURIN®

Composition:

Active substance: dry extract of common goldenrod herb;

One tablet contains 300 mg of dry extract of common goldenrod herb (Extractum Herbae Solidaginis virgaureae siccum) (5-7:1) (extraction solvent – ethanol 60%);

Excipients: magnesium stearate, crospovidone, silicon dioxide, microcrystalline cellulose, anhydrous colloidal silicon dioxide.

Pharmaceutical form. Tablets.

Main physicochemical properties: elongated biconvex tablets ranging from gray-green to greenish-brown in color, possibly with marbled surface appearance, with a score line on one side.

Pharmacotherapeutic group.

Other agents used in urology. Miscellaneous agents, including combinations. ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

Common goldenrod herb contains triterpenoid saponins, flavonoids, leucarposide, virgaureoside, and other active components. Goldenrod extract has a complex action: it possesses anti-inflammatory properties, diuretic (aquaretic) activity, and exerts a spasmolytic effect on the smooth musculature of the urinary tract. In addition, goldenrod extract demonstrates antibacterial activity, including against Staphylococcus aureus, St. epidermidis, St. faecalis, E. coli, Bacillus subtilis, and others. The active constituents of the extract also inhibit the growth of several fungi, including C. albicans, C. krusei, C. tropicalis, and others.

Goldenrod prevents stone formation by diluting urine and reducing the concentration of lithogenic substances in it. Since inflammation and narrowing of the urinary tract are associated with the presence of urinary stones, the diuretic and anti-inflammatory effects of goldenrod are particularly important for secondary prophylaxis. Therefore, Cysto-Aurin® is a primary treatment for inflammatory and infectious diseases of the urinary tract, as well as for their prevention.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Sanation of the urinary tract in inflammatory processes as part of complex therapy, in urolithiasis and presence of sand in the kidneys; prophylaxis in urolithiasis and presence of sand in the kidneys.

Contraindications.

Hypersensitivity to Solidago virgaurea or to other components of the medicinal product.

Should not be used in edema caused by cardiac or renal insufficiency.

Interaction with other medicinal products and other forms of interaction.

Not known.

Special precautions for use.

If there is blood in the urine, if body temperature rises, or if there is no improvement within 5 days, consult a physician.

Use during pregnancy or breastfeeding. The drug should not be used during pregnancy and breastfeeding, as such use has not been sufficiently studied.

Ability to affect reaction rate when driving or operating machinery. Has no effect.

Dosage and Administration.

For adults and children aged 12 years and older: 1 tablet 4–5 times daily.

The tablets should be taken whole, without chewing, and accompanied by sufficient liquid (e.g. a glass of water).

The duration of treatment is determined individually by a physician, depending on the nature and course of the disease.

Children.

Due to insufficient research data, the use of the drug is not recommended for children under 12 years of age.

Overdose.

There are currently no known cases of intoxication associated with taking Cysto-Aurinum® or other medicinal products containing common goldenrod herb. Overdose may enhance the symptoms listed in the section "Adverse Reactions". In case of accidental overdose, seek medical advice.

Treatment is symptomatic.

Side effects.

Gastrointestinal disorders: rarely (from ≥ 1/10000 to < 1/1000), nausea, vomiting, diarrhea were observed.

Immune system disorders: very rarely (< 1/10000) – allergic reactions (itching, rash).

If any adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging.

10 tablets per blister, 2 or 6 blisters per cardboard box.

Supply category. Over-the-counter.

Manufacturer.

Advans Pharma GmbH.

Manufacturer's address and place of business.

Wallenroder Str. 8-14, 13435 Berlin, Germany.

Marketing authorization holder.

Esparma GmbH, Germany.

Address of the marketing authorization holder.

Bielefelder Strasse 1, 39171 Süstedt, Germany.